Scientist - Packaging Development - client dedicated

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Job Description

Scientist - Packaging Development - Ware, UK

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our clients to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Summarized Purpose:

Essential Functions:

• Sipport delivery of the move to a newer vacuum decay process
• Testing of new bench top manufacturing equipment within the R&D packaging lab, experimenting on both various blister materials.
• Testing of the new seal integrity analysis equipment.
• Identifying ways of working, researching and comparing standard test methodology and developing instructions for use of the equipment.
• Lead the self-inspection audit schedule and responses to findings, communicating findings as well as good practices to the packaging Development team and complete or assign associated actions
• Accumulate and record prior knowledge data from a number of packaging development specific work packages
• Update specifications to ensure accurate information and references.
• Develop the packaging development strategy for bulk pack analysis, stability and preferred components for both drug substance and drug product
• Deliver sustainability assessments of different packaging container closure systems and New Product Introductions.
• Conduct Moisture modelling assessments of different packaging container closure systems and oral solid dose products. Identifying required desiccant levels for bulk and primary packaging presentations.
• Act as the lead experimental scientist who will carrying out laboratory based investigations on various developing coldform and thermoform blister base and lidding foils

Education and Experience:

• B.S./M.S. degree in Packaging Engineering/Packaging Science, Chemistry, Life Science, or equivalent industry experience,
• Proven experience in packaging development ideally within the pharmaceutical industry.

Knowledge, Skills and Abilities:

• Understanding of design control requirements associated with Medical Devices and Combination Products

• Knowledge of pharmaceutical packaging and technology, regulatory requirements, and the R&D, NPI, and technology transfer processes.

• Demonstrated track record for accomplishment in delivering projects, working within a complex, multi-disciplinary technical organization and matrix teams, working effectively across organizational, territorial, and cultural boundaries.

• Demonstrated ability to accomplish delivery of projects, meet project milestones, and manage multiple projects.

• Working knowledge of packaging materials, components, vendors, equipment, legislation, regulations, and technologies

• Demonstrated knowledge of domestic and international packaging requirements and regulations (i.e., current applicable FDA/MAA guidelines, USP/Ph Eur, etc).

• Knowledge of statistical analysis and Design of Experiments as they apply to packaging operations.

Our 4i Values:

Integrity - Innovation - Intensity - Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you